Brand Name | EEA 28MM SINGLE-USE STAPLER |
Type of Device | STAPLER, SURGICAL |
Manufacturer (Section D) |
COVIDIEN, FORMERLY USSC PUERTO RICO INC |
building 911-67 |
sabanetas industrial park |
ponce PR 00731 |
|
Manufacturer (Section G) |
COVIDIEN, FORMERLY USSC PUERTO RICO INC |
building 911-67 |
sabanetas industrial park |
ponce PR 00731 |
|
Manufacturer Contact |
sharon
murphy
|
60 middletown ave |
north haven, CT 06473
|
2034925267
|
|
MDR Report Key | 6038478 |
MDR Text Key | 57773713 |
Report Number | 2647580-2016-00840 |
Device Sequence Number | 1 |
Product Code |
GAG
|
UDI-Device Identifier | 10884523005530 |
UDI-Public | (01)10884523005530(17)210831(10)P6H0272KX |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K111825 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup,Followup |
Report Date |
09/21/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/31/2021 |
Device Model Number | EEA28 |
Device Catalogue Number | EEA28 |
Device Lot Number | P6H0272KX |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/26/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/21/2016 |
Initial Date FDA Received | 10/18/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 11/18/2016 02/28/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/01/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|